Mixing and dispensing apparatus

ABSTRACT

A mixing and dispensing apparatus having first and second containers. The first container has a main body portion which retains a first substance. A separate compartment is located in the first container and an internal passageway is formed between the main body portion and the compartment. The second container is configured to retain a second substance, and is compressible. The second container has a top end and a closed spout, wherein the closed spout is located in the compartment with the spout extending through the internal passageway into the main body portion of said first container. A release mechanism is formed by a plunger extending within the second container. The plunger has a first end in communication with the top end of the second container, and a second end aligned with the closed spout. The second end opens the closed spout when the second container is compressed to release the second substance into the main body portion of the first container.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to an apparatus for storing and shipping acomposition to be used in a clean environment. More particularly, thepresent invention relates to an apparatus which separately stores twosubstances, mixes the two substances when ready to be used in the cleanenvironment, and dispenses the mixed substances inside the cleanenvironment.

2. Background of the Related Art

A clean room is a space designed, maintained, and controlled to preventparticle and microbiological contamination of products. Certain chemicalcompositions are used inside clean rooms including, for instance,germicidal disinfectants such as phenols, cleaners, quaternary ammonium,peracetic acid, as well as various sporicides, such as peracetic acid,bleach, and hydrogen peroxide. The disinfectants and sporicides are usedin clean rooms to disinfect clean room surfaces. The compositions, whichare not naturally sterile, can be sterilized by filtration inside of theclean room.

To sterilize the compositions outside the clean room, the concentratedcomposition is either terminally sterilized by irradiation oraseptically processed. To terminally irradiation sterilize thecomposition, the composition is placed in a container, double bagged,and placed in a lined carton. The entire carton is then terminallysterilized by irradiation. A procedure for terminally irradiationsterilizing a composition is described, for instance, in U.S. Pat. No.6,123,900 to Vellutato, the disclosure of which is incorporated hereinby reference.

To aseptically process the concentrated composition, the composition issterilized through filtration and (inside a sterile environment) placedinto a container that has been pre-sterilized, such as by irradiation.The container can then be double bagged, also within the sterileenvironment. The double-bagged package is then removed from the sterileenvironment and placed into a carton having a liner. Aseptic processingis generally more labor intensive and expensive than terminalirradiation sterilization, and is typically only used for chemicals thatcannot be irradiation sterilized, such as peracetic acid, bleach andhydrogen peroxide.

When concentrated compositions are used, they first must be diluted withsterile water to the proper concentration for use. However, the dilutionbreaks down the compositions, and consequently the diluted compositionshave a relatively short shelf life of between about 17-30 days.Accordingly, clean room personnel typically dilute the concentratedcomposition just prior to actual use. To do so, once the sterileconcentrated composition enters the clean room (either through on-sitefilter sterilization, or off-site irradiation sterilization or asepticprocessing), it is typically manually mixed with a diluent (i.e., thesterile water) in a sterile container, such as a bucket, inside theclean room. The dilution and mixing has to be precise to ensure that theresulting concentration of disinfectant or sporicide will effectivelykill the desired microorganisms. The mixing is difficult to performmanually since the person performing the mixing is outfitted in cleanroom apparel, such as sterile garments and gloves. Accordingly, themixing is a time-consuming process that detracts from the time beingspent on other work being performed in the clean room.

A number of containers have been developed which separately store twosubstances and allow the two substances to be mixed together prior tobeing dispensed as shown, for instance, in U.S. Pat. No. 6,305,576 toLeoncavallo, U.S. Pat. No. 6,152,296 to Shih, and U.S. Pat. No.6,073,803 to Sturm. However, these patents are not well-suited for useto in a clean environment, including that they are not designed forshipment and sterilization, and can be difficult to use in a cleanenvironment. In addition, the present invention improves upon theAssignees previous inventions, including U.S. Pub. No. 2005/0163651 toVellutato, and U.S. Pat. No. 7,066,354 to Stank.

SUMMARY OF THE INVENTION

Accordingly, it is an object of the invention to provide a mixing anddispensing apparatus. It is another object of the invention to provide amixing and dispensing apparatus which is easy to use in a clean room bya user that is fully gowned and gloved. It is a further object of theinvention to provide a mixing and dispensing apparatus which is suitablefor use in a clean room.

A mixing and dispensing apparatus having first and second containers.The first container has a main body portion which retains a firstsubstance. A separate compartment is located in the first container andan internal passageway is formed between the main body portion and thecompartment. The second container is configured to retain a secondsubstance, and is compressible. The second container has a top end and aclosed spout, wherein the closed spout is located in the compartmentwith the spout extending through the internal passageway into the mainbody portion of said first container. A release mechanism is formed by aplunger extending within the second container. The plunger has a firstend in communication with the top end of the second container, and asecond end aligned with the closed spout. The second end opens theclosed spout when the second container is compressed to release thesecond substance into the main body portion of the first container.

These and other objects of the invention, as well as many of theintended advantages thereof, will become more readily apparent whenreference is made to the following description, taken in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a side view of the mixing and dispensing apparatus inaccordance with the preferred embodiment of the invention showing thelarge container with a cutaway view of the side compartment housing asecond container;

FIG. 2 is a rear view of the large container showing the compartment andneck taken along line A-A of FIG. 1;

FIG. 3( a) is a top view of the compartment taken along line B-B of FIG.1 showing the spout of the small container inserted in the wide portionof the passageway between the compartment and the large container;

FIG. 3( b) is a top view of the compartment taken along line B-B of FIG.1 with the small container rotated 180° so that the spout of the smallcontainer is in the locked position at the narrow portion of thepassageway;

FIG. 4 is a side view of the small container;

FIG. 5 is a bottom view of the small container showing the offset spout;

FIG. 6 is an exploded view of the small container and the releasemechanism;

FIG. 7( a) is a sectional view taken along line W-W of FIG. 5 with therelease mechanism engaged in the small container and in the readyposition;

FIG. 7( b) is a sectional view taken along line W-W of FIG. 5 with thesmall container compressed and the release mechanism breaking the foilseal over the small container spout;

FIG. 8 is a side view of the apparatus contained within sealing layers;

FIG. 9 is a perspective view showing the mixing and dispensing apparatusof FIG. 1 placed in a carton having a liner, in preparation forirradiation sterilization; and

FIG. 10 is a perspective view showing the carton of FIG. 9 closed andbeing irradiated in a plurality of different directions.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In describing a preferred embodiment of the invention illustrated in thedrawings, specific terminology will be resorted to for the sake ofclarity. However, the invention is not intended to be limited to thespecific terms so selected, and it is to be understood that eachspecific term includes all technical equivalents that operate in similarmanner to accomplish a similar purpose.

Turning to the drawings, FIG. 1 shows the mixing and dispensingapparatus 10 of the present invention. The apparatus includes a firstlarge container 20 and a second small container 50. The large container20 is preferably a spray bottle configured to receive the smallcontainer 50, and the small container 50 is preferably a round bellowedbottle. The containers 20, 50 are sized so that the small container 50fits inside a compartment of the large container 20.

The large container 20 has a main body portion 22 which retains a firstliquid, such as a diluent. An opening 24 is located at the top of themain body portion 22. The reservoir of the main body portion 22 of thelarge container 20 holds a predetermined amount of diluent, preferablyabout 8-32 ounces of sterile water, for use in the method of theinvention. The small container 50 retains up to about 0.5-2 ounces ofliquid.

The opening 24 is externally threaded to receive an optional dispensingmechanism 24. In the embodiment of FIG. 1, the dispensing mechanism 24is a manually-actuated spray head having a trigger and an adjustablenozzle. The nozzle can emit a nebulized spray or a stream spray. Itshould be appreciated, however, that other suitable dispensingmechanisms 24 can be utilized within the spirit and scope of theinvention, or that there need not be any dispensing mechanism 24 butrather that a cap is provided to close the opening 24. A dip tube 28extends from the dispenser mechanism 26 into the main body portion 22 toretrieve liquid stored in the reservoir of the main body portion 22.Upon manual actuation of the trigger, the dispensing mechanism 26retrieves the liquid from the main body portion 22 through the dip tube28 and forces it out of the nozzle of the dispensing mechanism 26.

A receiving portion 30 is integrally molded with the main body portion22. The receiving portion 30 includes a compartment 32 and a neck 34.The compartment 32 generally has a circular shape with a top 36 and abottom portion 38. An opening is located at the top 36 of thecompartment 32 and is threaded to receive a cover. The compartment 32 isseparate from the main body portion 22 and extends to one side of themain body portion 22. The compartment 32 has sides which aresubstantially parallel to the sides of the main body portion 22. Theside of the compartment 32 closest to and facing the main body portion22 is connected to the side of the main body portion 22 closest to thecompartment 32, by a thin elongated web member 39. The web member 39preferably extends a substantial amount of the height of the compartment32 side. The web member 392 affixes the compartment 32 to the main bodyportion 2 and supports the compartment against side-to-side movement.

The compartment 32 forms a chamber that receives the second container50. The top 36 opening permits the small container 50 to be introducedinto and fully positioned inside the compartment 32 of the largecontainer 20.

The neck has one end 33 in flow communication with the main body portion22, an opposite end 35 in flow communication with the small container 50in the compartment 32, and an intermediate portion between the two ends33, 35. Thus, the neck 34 connects the compartment 32 to the main bodyportion 22 so that the small container 50 is in fluid communication withthe main body portion 22. The neck extends from a side of the main bodyportion 22 toward the bottom of the main body portion 22, to the bottomportion 38 of the compartment 32. The compartment 32 and the main bodyportion 22 are substantially parallel to one another, with thecompartment 32 extending immediately at one side of the main body 22.The neck 34 has a ramp at the bottom which is at an angle to the mainbody portion 22, preferably about 30-45 degrees. And, the ends 33, 35are substantially perpendicular to each other; with the end 33 at themain body portion 22 being substantially vertical and the end 35 at thecompartment 32 when the dispenser 10 is sitting on the bottom of themain body 22. As shown in FIG. 2, the neck 34 is fairly wide, thoughnarrower than the main body portion 22 and the compartment 32, which areapproximately the same width as each other.

As shown in FIGS. 1 and 2, a passageway 40 is located between thecompartment 32 and the neck 34. The passageway 40 is formed by anannular depression 42 that creates a plate or platform 44, so that thepassageway 40 is integrally molded as part of the large container 20,together with the compartment 32 and the neck 34. The internal side ofthe platform 44 forms the floor at the bottom portion 38 of thecompartment 32. The passageway 40 is formed in the platform 44 so as toprovide an opening into the neck 34 from the compartment 32. The smallcontainer 50 can be placed in the compartment 32 of the large container20 through the top opening 36, and the spout 52 of the small container50 positioned in the passageway 40. The spout 52 of the small container50 can then be opened and the contents of the small container 50 emptiedinto the reservoir of the large container 20. The top surface ofplatform 38 supports the small container 40 in the chamber of neck 24.

The internal passageway 40 is further shown in FIGS. 3( a), (b) lookinginto the inside of the compartment 32. The passageway 40 is shown as anopening formed in the bottom of the compartment 32, where the bottom isformed by the inward depressions 42 formed in the container 20. Theedges of the depression 42 form the passageway 40. As shown, thepassageway 40 has a generally keyhole shape with a wide portion 41 and anarrow portion 43. The passageway 40 is symmetrical about its centrallongitudinal axis, with wide portion 41 formed as two opposing wingshaving tips. The passageway 40 narrows inward from the wing tips, thenstraightens at the narrow portion 41. The distal ends of the narrowportion 43 and the wide portion 41 are curved. The wide portion 41 islocated off-center with respect to the center of the compartment 32.

As best shown in FIGS. 1, 3(a), 3(b), a flexible plastic barrier 70 ispreferably also positioned inside the compartment 42 about a portion ofthe small container 50. The barrier 70 stabilizes the small container 50within the compartment 32 and keep it properly positioned in thepassageway 40. The barrier 70 is generally formed as a rectangle with alength that is slightly smaller than the diameter of the compartment 32.Accordingly, the barrier 70 can bend within the compartment 32 and besupported by the inside of the walls of the compartment 32 atapproximately a diameter of the compartment 32. The barrier 70 has aheight about the same as the height of the bellows on the smallcontainer 50, so that the full height of the small container 50 issupported against the barrier 70.

The small container 50 is shown in FIG. 4 in greater detail. The smallcontainer 50 has a bottom cylindrical opening or spout 52, a top end 54opposite the bottom end which is formed as a spout 52, and anintermediate portion 56 therebetween. The spout 52 extends outward fromthe intermediate portion 56 to form a cylindrical neck 51. A lip 53 isformed at the extreme distal end of the spout 52. The lip 53 is widerthan the neck 51. The top end 54 also preferably projects outward fromthe intermediate portion 56 in a direction opposite to the bottom spout52. The top opening is externally threaded to threadably engage aninternally threaded cap.

In accordance with a preferred embodiment of the invention, theintermediate portion 56 of the small container 50 comprises a bellowedreservoir body which retains a liquid. Accordingly, the intermediateportion has a number of compressible bellows 59. Though the entireintermediate portion 56 is shown having bellows 59, it will be apparentthat only a section of the intermediate portion 56 can have bellows 59.The intermediate portion 56 is wider than the spout 52. The intermediateportion 56 can have a smaller section which leads into the neck 51. Thebellows 59 are arranged in an accordion-like style so that the top end54 can be compressed toward the bottom end spout 52, and can also beextended so that the top end 54 can be moved apart from the bottom endspout 52.

Turning to FIGS. 3( a), (b), the manner in which the small container 50engages the internal passageway 40 of the large container 20 is shown.Referring momentarily to FIG. 5, the spout 52 is off-centered withrespect to the intermediate body portion 56 of the small container 50.Accordingly, returning to FIG. 3( a), the small container 50 can beplaced inside the compartment 32 of the large container 20 with thesmall container 50 oriented so that the spout 52 is aligned with thewide portion 41 of the passageway 40.

When inserted into the chamber of the compartment 32, the smallcontainer 50 is lowered so that the spout 52 is aligned with andreceived by the wide portion 41 of the passageway 40. As shown by thedashed lines, the small container 50 is offset within the compartment 32for the alignment to be made. The lip 53 and neck 51 pass through thepassageway 40, but the wider portion of the intermediate portion 56 iswider than the wide portion 41 of the passageway 40. Accordingly, thespout 52 comes to rest in the passageway 40 with the neck 51 positionedin the passageway 40 itself, the lip 53 positioned outside thepassageway 40 in the neck 34 of the large container 20, and theintermediate portion 56 positioned in the compartment 32.

At that point, the small container 50 is positioned inside thecompartment 32 and the spout is aligned in the wide portion 41 of thepassageway 40; but the small container 50 is not yet fixed to the largecontainer 20. The small container 50 is then given a half turn (180°),as represented by the arrow X in FIG. 3( b). As the small container 50is rotated, the spout 52 of the small container 50 travels in thedirection of arrow Y (to the left in the embodiment shown) by virtue ofbeing offset on the small container 50, such that the spout 52 entersthe narrow portion 42 of the passageway 40. In addition, the smallcontainer 50 is realigned within the compartment 32 in the direction ofthe arrow Z (to the right in the embodiment) since the spout 52 isoffset. The spout 52 is able to enter the narrow portion 42 of thepassageway 40 since the neck 51 of the spout 52 is smaller than thenarrow portion 42. However, the lip 53 and widened intermediate portion56 are wider than the narrow portion 42. The lip 53 prevents the spout52 from being pulled upward out of the narrow portion 42 of thepassageway 40. Accordingly, the small container 50 is in a fixedposition within the passageway 40 so that the small container 50 isengaged with the large container 20. In the fixed position, the spout 52is aligned through the passageway 40 with the neck 34 of the largecontainer 20 so that any fluid released from the spout 52 will directlyenter and mix with fluid in the large container 20 without anyobstruction.

In FIG. 3( b), the barrier 70 is shown in the compartment 32 positionedabout the wide portion 41 and at an opposite side of the small container50 as the spout 52. The bather 70 operates as a spring force to exert apressure against the small container 50 which forces the spout 52 of thesmall container 50 into the narrow portion 43 of the passageway 40. Thebarrier 70 can be placed into the compartment 32 before the smallcontainer 50 is placed in the compartment 32, as in FIG. 3( a). Or, thebarrier 70 can be placed into the compartment 32 after the smallcontainer 50 is rotated and aligned with the narrow portion 43 of thepassageway 40, as in FIG. 3( b). Once the spout 52 is in the narrowportion 43 of the passageway 40, the barrier 70 maintains the force onthe small container 50 to prevent the spout 52 from entering the wideportion 41 of the passageway 40. When the small container 50 is rotatedinto the narrow portion 43 (FIG. 3( b)), the body portion 56 of thesmall container 50 is pushed by the barrier 70 toward the narrow portion43 of the passageway 40. The spout 52 and passageway 40 can also beconfigured so that the small container 50 moves further into the barrier70 when rotated so that the barrier 70 in return exerts a greater forceon the small bottle 50 to better retain the small container 50 inposition in the narrow portion 43 of the passageway 40.

Turning to FIG. 6, the release mechanism 60 is shown. The releasemechanism 60 includes a container cap 62, plunger 80 and retainer 64.The cap 62 is internally threaded to threadingly mate with the top end54 of the small container 50. The cap 62 has side walls which form acenter well. The plunger 80 is an elongated member having a head 82 atone end, prongs 86 at an opposite end and an intermediate portion 84therebetween. The head 82 is a cylindrical section which is wider thanthe intermediate portion 84. The intermediate portion 84 and the prongs86 have a cross- or plus-shaped cross-section. The intermediate portion84 is wider at the top by the head 82 and tapered toward the bottom atthe prongs 86. The prongs 86 form an arrow-like tip to the plunger 80which can be relatively sharp.

The retainer 64 is a cylindrical member with a center opening whichreceives the plunger 80. The center opening is smaller than the head 82of the plunger, so that the head 82 cannot pass through the opening ofthe retainer 64. The retainer 64 is relatively flexible, butsufficiently rigid so that it can frictionally fit within the centerwell of the cap 62. The release mechanism 60 is assembled by placing theplunger 80 through the retainer 64 until the retainer 64 is against thehead 82. The retainer 64 may have a central depressed portion whichreceives the head 82 of the plunger 80. As best shown in FIG. 7( a), theretainer 64 is then pressed into the well of the cap 62 until theretainer 64 and the head 82 are fully received in the well of the cap62. The retainer 64 retains the head 82 in the cap 62 by virtue of thefriction fit between the retainer 64 and the walls of the cap 62. Inaddition, the top leading edge of the walls of the head 82 press theretainer 64 against the inside top of the cap 62.

The operation of the system will now be described starting with FIG. 6,where the small container 50 is filled with a first liquid such as aconcentrated cleaner with the bellows 59 in an expanded state. And, thelarge container 20 (FIG. 1) is filled with a second liquid such as adiluent. Sterile water is filtered at 0.2 microns into the main bodyreservoir 22 of the large container 20. The large container 20 is filledwith the first substance through the opening 24 at the top of the largecontainer 20. The large container 20 and the small container 50 arefilled in two separate operations so that there is no accidental mixtureof chemical agents. The contents of the containers 20, 50 thus remainseparate until the mixing and dispensing apparatus 10 is ready for useby the user.

A concentrated chemical composition, such as a disinfectant, is filteredat 0.2 microns into the small container 50. The small container 50 hasthe foil 72 placed over the spout 52, so that the liquid remains withinthe small container 50 reservoir. In operation, the diluent and thechemical composition are assayed separately to ensure that properformulations have been received. The composition and diluent arefiltered with a 0.2 micron filter to remove particulates, and aparticulate test is conducted. The composition and diluent are thenmeasured to ensure that the proper dilution will result when they areeventually mixed together.

Turning to FIG. 7( a), the release mechanism 60 is then placed withinthe interior of the small container 50, with the plunger extending downthrough the intermediate portion 56. The release mechanism 60 is thenengaged with the small container 50 by screwing the cap 62 onto the topend 54 of the small container 50. At that point, the top end 54 of thesmall container 50 is aligned with the spout 52 at the bottom end of thesmall container 50, so that the plunger 80 and prongs 86 are alignedwith the spout 52 without touching the sides of the small container 50.

Once the small container 50 is filled and the release mechanism 60 isfixed to the small container 50, the small container 50 is placed insidethe compartment 32 of the large container 20, as shown in FIG. 1. Thespout 52 is aligned with the wide portion 41 of the passageway 40, FIG.3( a), and the small container 50 is then rotated 180° so that the smallcontainer 50 is fixed within the narrow portion 42, FIG. 3( b). Thebather 70 maintains a pressure against the small container 50 so thatthe spout 52 does not come free of the narrow portion 42 of thepassageway 40.

Thus, as shown in FIG. 8, the apparatus 10 has the first liquid in thelarge container 20 and the second liquid in the small container 50, andwith the small container 50 fixed to the large container 20. Theapparatus 10 is not ready for use. Since the apparatus 10 will be usedin a clean room, the apparatus 10 is irradiation sterilized. Theapparatus 10 is placed in a first sealing layer 12 and hermeticallysealed by heat to form a single layer sealed enclosure. The single layersealed enclosure can then be inserted into a second sealing layer 14 andhermetically sealed by heat to form a second layer sealed enclosure. Thefirst and second sealing layers 12, 14 are a polyethylene composition.Turning to FIG. 9, the double layer sealed enclosure can then beinserted into a carton 90 having a plastic liner 92. The plastic liner92 is closed by tying or the like to form a third sealing layer.Finally, the carton is closed and prepared for shipping.

The carton 90 is then ready for irradiation, which is shown in FIG. 10.Gamma radiation is used since it has high penetration capability thatenables relatively dense products or compositions to be processedeasily. Sterilizing doses generally are in the 25-50 kGy (kilogray)range. To ensure proper dosage, the radiation is measured by dosimetersthat measure the amount of irradiation impinging on the carton. Theirradiation sterilizes the entire packaging, including the first, secondand third sealing layers, the air contained within each layer, as wellas the entire apparatus 10, the chemical composition in the smallcontainer and the diluent in the large container.

In this manner, when received at the operational site, the closedcartons may be opened and the liner 92 with the double-bagged chemicalcontainers 10 contained therein may be removed on a loading dock priorto entry into a clean room area and the carton 90 discarded. Thechemical containers 10 are maintained within the closed third sealinglayer or liner 92 until removed and then brought to a clean roomoperating site. The liner is used in the preferred embodiment to preventcarton particles from contaminating the outermost sealing layer 14.Depending on the particular application, the carton liner 92 need not beused, e.g., when sterility of the exterior of the sealing layer 14 is ofno concern.

Once transported into the clean room area or other operational site, thethird sealing layer may be removed and the container 10 within the firstand second sealing layer enclosures 12, 14 may be placed on a shelf forfuture use. When placing the sealed container enclosures on the shelvesfor use in clean rooms, generally sterilized gloves are used, however,these in themselves as well as the atmosphere of clean rooms havevarious particulates, such as microbes or bacteria, which dictate arelatively short shelf life for container 10 if only a single firstlayer 14 were formed around the container 10. However, with the firstand second layers 12 and 14, the now somewhat less than sterilizedsecond layer sealed container enclosure may be kept on the shelf for anindefinite period of time prior to use of the contents of the container10.

Once the contents of the container 10 are to be used, the second sealinglayer 14 may be stripped from the second layer sealed containerenclosure leaving the first layer 12 surrounding and encasing thecontainer 10 in a sterilized manner. Use then can be made of thecontents of container 10 with the assurance that such has beenmaintained in a sterilized state.

At this point, the user can use the contents of the containers 20, 50,which are sterile, as follows. The cap 36 of the compartment 32 isremoved to grant access to the small container 50. Turning to FIG. 7(b), the user presses downward on the cap 62 of the small container 50 inthe direction of the arrow shown. This compresses the bellows 59 andmoves the top end 54 closer to the bottom spout 52. Eventually, theprongs 86 of the plunger 80 contact and pierce the foil seal 72 of thespout 52 to create an opening in the foil seal 72. The plunger 80continues to push through the foil seal 72 and can continue to extendthrough the spout 52 to ensure that a large opening is made in the foil72. Because the plunger 80 and prongs 86 have “+” shaped cross sections,there is plenty of space between the plunger and prong walls and theopening created in the foil 72 for liquid to pass out of the spout 52past the plunger 80 and the prongs 86.

The user continues to push down on the top of the small container 50until the bellows 59 are fully compressed, as shown in FIG. 7( b). Thepushing (as well as gravity) forces the contents of the small container50 out through the spout 52. It is not necessary to provide an air ventin the small container 50 since the fluid is emitted by the compressionof the small container 50. Since the spout 52 is in direct flowcommunication with the neck 34 of the large container 20, the contentsof the small container 50 are discharged directly into the contents ofthe large container 20. The contents of the small container 50 aredischarged by the compression of the small container 50, even if diluentis present in the neck 34 and compartment 32. The user then replaces thecap 36 on the compartment 32 and if desired, can shake the entireapparatus 10 to further combine the contents of the two containers. Thethus mixed contents can then be dispensed from the large container 20through the dispensing mechanism 26 via the dip tube 28.

Chemical compositions can also be aseptically processed when beingfilled into the apparatus 10. The chemical composition can be filtersterilized, and the apparatus 10 sterilized by radiation. Thecomposition can then be filled into the containers in a cleanenvironment, and then placed in sterilized successive sealing layersthat are hermetically sealed, and placed in a carton having a liner. Allcomponents in the aseptic filling operation are presterilized via gammaradiation and transferred to the clean (usually Class 100) asepticfilling environment, other than the composition, which is filtersterilized. In such area, all personnel are completely gowned inpresterilized coveralls, hoods, boots, masks and goggles. The clean roomis monitored for particulates and microbials. However, asepticprocessing is generally more complicated and labor-intensive, andtherefore is more appropriate for compositions that are not suitable forsterilization through irradiation, such as peracetic acid and hydrogenperoxide.

Thus, in both the terminal irradiation and the aseptic processing, themixing occurs just prior to actual use, so that the mixture is fresh andeffective. The mixture is made under sterile conditions inside thesterile container, so that the resulting mixture is sterile. Inaddition, the contents are measured when filled into the apparatus.Thus, the user does not have to make any measurement of the chemicalcomposition or the diluent in the clean room, and can still be certainthat the proper assay is achieved.

A foil 72 is utilized since it doesn't break or shatter, but insteadpierces when contacted by the prongs 86. Thus, there are no loose piecesof the foil 72 or the prongs 86 which might otherwise enter into theliquid contents and contaminate the clean room. In addition, by usingthe dip tube 28 and the spray mechanism 26, no foreign particles areable to enter the clean room. In addition, a filter can be placed overthe end of the dip tube 28 to further filter any particles that might bein the liquid. And, while the invention has been described for use witha spray bottle, other suitable containers can be utilized such as agallon container having a filter over the spout for pouring.

Any suitable configuration of the apparatus 10 can be made, withoutdeparting from the spirit and scope of the invention. For instance, thesmall container need not be a separate container, but can be acompartment that is integral to the large container. However, theapparatus 10 is advantageous since it requires minimal manipulation by auser who is fully gowned in a clean room and wearing gloves. All theuser needs to do is open the top of the compartment 32 and push down onthe small container 50. The small container 50 and bellows 59 aresufficiently rigid to stand independently, and is protected by thecompartment 32 during transport to prevent inadvertent or unintendedcollapse of the small container 50.

It is further noted that the mixing and dispensing apparatus 10 is easyto actuate by the gloved hand. The apparatus 10 substantially maintainsthe shape of a standard spray bottle. So, the user can easily grasp thetop of the bottle and use the actuating spray handle withoutinterference by the compartment 32 and the small container 50. Inaddition, the small container 50 and compartment 32 are cylindrical, butthat other suitable shapes can be utilized. In addition, the largecontainer 20, the plunger 80 and the small container 50 are each singleunitary molded pieces made of plastic.

In accordance with the preferred embodiment, the apparatus 10 is about13 inches tall from the bottom to the top of the dispensing mechanism26. The main body portion is about 4.5 inches wide up to the junction 33with the neck 34, and about 3 inches deep. The compartment is about 2.75inches in diameter, and the small container 50 has a diameter of about2.25 inches. The barrier 70 is 3 inches in length by about 1.75 inchestall.

The foregoing description and drawings should be considered asillustrative only of the principles of the invention. The invention maybe configured in a variety of shapes and sizes and is not intended to belimited by the preferred embodiment. Numerous applications of theinvention will readily occur to those skilled in the art. Therefore, itis not desired to limit the invention to the specific examples disclosedor the exact construction and operation shown and described. Rather, allsuitable modifications and equivalents may be resorted to, fallingwithin the scope of the invention.

1. A mixing and dispensing apparatus comprising: a first containerhaving a main body portion retaining a first substance and a compartmentwith an internal passageway between the main body portion and thecompartment; a second container configured to retain a second substance,said second container being compressible and having a top end and aclosed spout, wherein the closed spout is located in said compartmentwith the spout extending through the internal passageway into the mainbody portion of said first container; and, a plunger extending withinsaid second container and having a first end in communication with thetop end of said second container, and a second end aligned with theclosed spout, whereby the second end opens the closed spout when saidsecond container is compressed to release the second substance into themain body portion of said first container.
 2. The apparatus of claim 1,wherein said apparatus is configured for use in a clean room.
 3. Theapparatus of claim 1, further comprising a foil positioned over thespout to close the spout.
 4. The apparatus of claim 3, wherein theplunger pierces the foil to create an opening in the foil when thesecond container is compressed.
 5. The apparatus of claim 1, furthercomprising a flexible barrier positioned in said compartment about saidsecond container.
 6. The apparatus of claim 1, further comprising: anopening at the top end of said second container; a cover for closingsaid opening, said cover having a central bore; a head located at thefirst end of said plunger and received in the central bore of saidcover; and a retainer positioned about said head for retaining theplunger in the central bore of said cover.
 7. The apparatus of claim 6,further comprising prongs at the second end of said plunger, said prongspiercing the closed spout.
 8. The apparatus of claim 1, wherein saidspout is offset on the main body portion of said second container. 9.The apparatus of claim 1, wherein said second container has a neckconfigured to be received in the passageway.
 10. The apparatus of claim9, further comprising a wide lip extending outward from said neck. 11.The apparatus of claim 10, wherein said passageway has a wide portionand a narrow portion, wherein the narrow portion is narrower than thewide lip, and wherein the spout neck and lip are received in the wideportion and moved into the narrow portion such that the wide lip is on afar side of the passageway.
 12. The apparatus of claim 1, wherein saidcompartment is separate and apart from said main body portion, andfurther comprising a neck connecting said compartment to said main bodyportion.
 13. The apparatus of claim 12, wherein said compartment issubstantially parallel with said main body portion.
 14. The apparatus ofclaim 1, wherein said main body portion substantially comprises a spraybottle.